RecallDepth

Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;

Company
Abbott Diabetes Care, Inc.
Recall Initiated
December 22, 2010
Posted
February 9, 2011
Terminated
October 25, 2011
Recall Number
Z-1000-2011
Quantity
359 total lots, 1,000,000 strips per lot
Firm Location
Alameda, CA

Reason for Recall

Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.

Distribution

Products were released for distribution in US and Puerto Rico.

Lot / Code Info

Lot codes:  45358, 45369, 45377, 45379, 45466, 45504, 45511, 45608, 45613, 45641, 45642, 45644, 45672, 45674, 45675, 45676, 45677, 45721, 45734, 45736, 45739, 45742, 45743, 45789, 45790, 45800, 45801, 45840, 45841, 45849, 45850, 46008, 46009, 46061, 46067, 46069, 46072, 46103, 46105, 46148, 46201, 46202, 46214, 46215, 46232, 46313, 46332, 46336, 46338, 46341, 46368.

Root Cause

Process control

Action Taken

On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned.

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